Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin
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Hepatitisweb study
Hepatitisweb study
Peginterferon alfa-2b + Ribavirin versus
Interferon alfa-2b + Ribavirin
Phase 3
Treatment Naïve, Chronic HCV
Manns MP, et. al. Lancet. 2001;358:958-65
Hepatitisweb study
Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Study Design
• Study- Open-label, randomized controlled trial - 62 sites in Europe, North America, & Argentina
• Subjects- N = 1530 with chronic hepatitis C- Treatment naïve- Genotype 1: 68%; Genotype 2 or 3: 29%; Genotype 4,5, or 6: 3% - Serum ALT >34 IU/L for women, >43 IU/L for men
• Regimens- Higher Dose Peginterferon alfa-2b: 1.5 µg/kg 1x/week + ribavirin 800 mg/day- Lower Dose Peginterferon alfa-2b: 1.5 µg/kg 1x/week x 4 weeks then 0.5 µg/kg 1x/week + ribavirin 1000-1200 mg/day*- Standard interferon alfa-2b: 3 million U 3x/week + ribavirin 1000-1200 mg/day*
• Primary Endpoint (Sustained Virologic Response [SVR])- SVR = Undetectable serum HCV RNA 24 weeks after 48-week treatments
Source: Manns MP, et. al. Lancet. 2001;358:958-65.
*Ribavirin dosing: <75 kg: 1000 mg/day; >75 kg: 1200 mg/day
Hepatitisweb study
Higher-Dose Peginterferon + Ribavirin--------------------------------------------------------------------
Peginterferon alfa-2b: 1.5 µg/kg 1x/week + Ribavirin: 800 mg/day
Interferon + Ribavirin--------------------------------------------------------------------
Standard Interferon alfa-2b: 3 million U 3x/week +Ribavirin: 1000-1200 mg/day
Lower-Dose Peginterferon + Ribavirin--------------------------------------------------------------------
Peginterferon alfa-2b: 1.5 µg/kg 1x/week x 4 weeks, then 0.5 mcg/kg 1x/week + Ribavirin: 1000-1200 mg/day
From: Manns MP, et. al. Lancet. 2001;358:958-65.
Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Study Design
N = 514
N = 511
N = 505
48 720Week
SVR24
SVR24
SVR24
Hepatitisweb study
End of Treatment Response Sustained Virologic Response0
20
40
60
80
100
65
5456
4754
47
Higher-dose Peginterferon + Ribavirin (low dose)
Lower-dose Peginterferon + Ribavirin (weight dose)
Interferon + Ribavirin (weight dose)
Patie
nts
(%)
Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Results
Response after 48 Weeks of Treatment
Source: Manns MP, et. al. Lancet. 2001;358:958-65.
274/511 244/514 235/505333/511 289/514 271/505
Hepatitisweb study
Genotype 1 Genotype 2/3 Genotype 4/5/60
20
40
60
80
100
42
82
50
34
80
3333
79
38
Higher-dose Peginterferon + Ribavirin (low dose) Lower-dose Peginterferon + Ribavirin (weight dose) Interferon + Ribavirin (weight dose)
Patie
nts
(%) w
ith S
VRPeginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin
Results
SVR24, Based on Genotype
Source: Manns MP, et. al. Lancet. 2001;358:958-65.
Hepatitisweb studySource: Manns MP, et. al. Lancet. 2001;358:958-65.
Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + RibavirinIDEAL Study: Conclusions
Interpretation: “In patients with chronic hepatitis C, the most effective therapy is the combination of peginterferon alfa-2b 1.5 µg/kg per week plus ribavirin. The benefit is mostly achieved in patients with HCV genotype 1 infections.”
Hepatitisweb study
Hepatitisweb study
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects.
Hepatitis C Onlinewww.hepatitisc.uw.edu
Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/
Funded by a grant from the Centers for Disease Control and Prevention.
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